There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to ...

Measuring and fulfilling user requirements during medical device development will result in successful products that improve patient safety, improve device effectiveness and reduce product recalls and modifications. Medical device users are an extremely heterogeneous group and for any one device the users may include patients and their carers as well as various healthcare professionals. There a...

Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the source is credited. DOI 10.3109/17453674.2014.1002185 Background Against the background of several major adverse incidents involving orthopedic implants, such as the Articular Surface Rep...

When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability fra...

purpose: to report and evaluate the characteristics of patients referred to the emergency department of labbafinejad medical center with work-related eye injuries during 2005.  methods: in this descriptive study, an available sample of patients with work-related eye injures were assessed. demographic characteristics, causes of ocular trauma, and use of work safety devices were main evaluated va...

No recent pharmaceutical or medical device has generated as much ongoing and expanding attention as drug-eluting stents (DES). In fact there has been an explosion of published reports on the topic within cardiology, medical, surgical and subspecialty journals. The device industry has repeatedly sent their own summaries of information directly to physicians, while mainstream media has kept the c...

BACKGROUND To explore factors that influence and to identify initiatives to improve the recognition, reporting and resolution of device-related incidents. METHODS Semi-structured telephone interviews with 16 health professionals in two tertiary care hospitals were conducted. Purposive sampling was used to identify appropriate study participants. Transcribed interviews were read independently ...